India bars routine stem cell therapy for limb ischemia, chronic wounds

The health ministry has issued strict guidelines barring the routine clinical use of stem cell therapy for critical limb ischemia and chronic wounds, permitting it only within authorised research trials. Officials cited 'rampant use of this experimental therapy despite limited knowledge of its safety and efficacy' and said there is little evidence of clinical benefits.

A multidisciplinary panel reviewed randomised controlled trials and found 'very low certainty' of benefit for both conditions. For critical limb ischemia, the ministry noted a non-significant reduction in major amputations and no meaningful advantage in ulcer healing, pain-free walking distance or mortality. An identical recommendation applies to chronic wounds from diabetes, venous insufficiency or leprosy.

Trials using minimally manipulated cells require ethics committee approval and cell counts, trials with more than minimal manipulation need additional clearance from the Central Drugs Standard Control Organization. India's regenerative medicine market, including stem cell therapy, was valued at Rs 7,641 crore in 2024 and is projected to reach Rs 4.33 trillion by 2033.